Magnesium Sulphate Versus Fentanyl for Conscious Sedation in CSDH (CSDH)

December 1, 2018 updated by: Rania Samir Fahmy, Kasr El Aini Hospital

Magnesium Sulphate Versus Fentanyl as Adjuvants to Propofol Xylocaine Combination for Conscious Sedation During Chronic Subdural Haematoma Surgery. Comparative Study

The investigators hypothesize that magnesium sulphate owing to its analgesic and sedative properties is not inferior to fentanyl in providing conscious sedation as adjuvants to propofol and local injection of lidocaine in patients undergoing surgery for evacuation of subdural haematoma. Consequently, the investigators are testing this hypothesis by comparing the sedative and analgesic effects of magnesium sulphate versus fentanyl as adjuvants to propofol lidocaine admixture for conscious sedation in patients undergoing burr hole surgery for evacuation of subdural haematoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following institutional ethical committee approval, 34 patients undergoing burr-hole surgery for chronic subdural hemorrhage were included in this prospective, randomized, double-blind study.

Written informed consent were obtained from all subjects before enrollment in the study.

During the preanesthetic checkup,the operative procedure and anesthetic techniques were explained to all patients.

Upon arrival to operating theater, standard monitoring were applied to all patients and bispectral index was applied before starting the drug infusions and was used for maintenance of sedation during operation.

Subjects were randomized into 2 groups. Magnesium (M) group received Magnesium sulphate 50mg/kg IV over 15 minutes Followed by continuous infusion at 15 mg/kg/h Fentanyl (F) group received fentanyl 1 μg /kg IV bolus over 15 minutes Followed by continuous infusion starting at 0.5 μg /kg/h Loading and infusion doses of magnesium sulphate and loading doses of fentanyl were chosen from previous studies.

In both groups fentanyl and magnesium sulphate were accompanied by IV propofol at a dose of 50- 150 μg /kg/min bolus over 10 minutes to achieve target sedation level, that is, Ramsay sedation scale (RSS) 3, if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol were given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80 After achieving predefined target sedation level (RSS of 3), surgeons infiltrated the sites of the burrholes with 20 mL of a local anesthetic solution containing 10 mL of 0.5% bupivacaine and 10 mL of 2% lidocaine with adrenaline infiltrated locally at least 5 minutes before surgical incision. After burr-hole craniotomy followed by the hematoma evacuation is accomplished, the Infusion of sedatives were discontinued just after placement of the final skin suture.

Intraoperative patient's movement is defined as those likely to interfere with surgical procedure such as bending of hand and/or leg and movement of head were recorded. The first intervention is to attempt patient reassurance for 30 seconds. If movement continues then the bolus dose of propofol of 0.5 mg/kg was given and infusion dose was increased in the previously described manner till the maximum dose to regain BIS sedation score between 60-80.

If the patient starts to move again the same sequence was repeated. Induction of general anesthesia was deemed the final intervention in case satisfactory condition was not achieved within the rescue propofol.

All patients were transferred to the post-anesthesia care unit (PACU) after surgery.

The data collected are:

  1. Total amount of Propofol consumption.
  2. Total number of patient movements
  3. The intraoperative and postoperative hemodynamic data
  4. VAS (Visual analogue scale for pain) score
  5. Time to first rescue analgesic
  6. Adverse events
  7. Surgeon satisfaction score was recorded.

Statistical analysis:

Data was analyzed using SPSS © Statistics version 23 (IBM© Corp., Armonk, NY, USA). Chi-square test (Fisher's exact test) was used to examine the relation between qualitative variables. For quantitative data, comparison between the two groups was done using independent sample t-test or Mann-Whitney test as appropriate. All tests were two-tailed. A p-value < 0.05 was considered significant.

Sample Size calculation:

A previous study reported that pre-procedure magnesium sulphate reduced the total propofol requirements to 130±19.09 mg compared to 172.8±29.09 mg with pre-procedure fentanyl. Based on these results, a sample size of 15 cases in each group was satisfactory to elicit the difference at an alpha level of 0.05 and a power of the test of 95%. The sample size was increased to 17 per group to compensate for possible dropouts.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasr El Aini Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

51 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > 50 years
  • ASA (American Society of Anesthesiologists physical status) grade I to II
  • Glasgow coma scale 14-15
  • Unilateral chronic subdural hematoma

Exclusion Criteria:

  • Hypertension (diastolic blood pressure > 160 mmHg)
  • Bradycardia (<50 bpm)
  • Ischemic heart disease (<6 months)
  • Second- or third-degree heart block
  • Long-term abuse of or addiction to alcohol, tobacco, opioids, and sedative-hypnotic drugs (>6 months)
  • Allergy to study drugs
  • Neuropsychiatric diseases
  • Predicted difficult airway according to Ganzouri score >4.
  • Patients with deviation in the surgical technique or with inadequacy of local anesthesia were excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnesium (M) group
Magnesium (M) group (n=17) , in which magnesium sulphate is given as adjuvant to propofol for sedation
Drug: Magnesium sulphate
Magnesium sulphate will be given to the experimental group in a dose of 50mg/kg IV over 15 minutes followed by continuous infusion at 15 mg/kg/h
Drug: Propofol
In both groups Fentanyl and magnesium sulphate will be accompanied by IV propofol at a dose of 50- 150 μg /kg) bolus over 15 minutes to achieve target sedation level, that is Ramsay sedation scale (RSS) 3,if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80%
Active Comparator: Fentanyl (F) group
Fentanyl (F) group (n=17), in which fentanyl is given as adjuvant to propofol for sedation
Drug: Propofol
In both groups Fentanyl and magnesium sulphate will be accompanied by IV propofol at a dose of 50- 150 μg /kg) bolus over 15 minutes to achieve target sedation level, that is Ramsay sedation scale (RSS) 3,if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80%
Drug: Fentanyl
Fentanyl will be given to the active comparator group in a dose of 1 μg /kg IV bolus over 15 minutes followed by continuous infusion starting at 0.5 μg /kg/h

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of Propofol consumption in each group
Time Frame: From the start of propofol infusion after arrival to the operating room and throughout the duration of the surgery
To measure total amount of propofol consumption from induction of conscious sedation till the end of the operation and to compare it between both groups
From the start of propofol infusion after arrival to the operating room and throughout the duration of the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To measure the total number of intraoperative patient's movements
Time Frame: From the start of the surgery and throughout the duration of the surgery
Intraoperative patient's movement is defined as those likely to interfere with surgical procedure such as bending of hand and/or leg and movement of head
From the start of the surgery and throughout the duration of the surgery
Heart rate
Time Frame: Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU
Heart rate in beats/min
Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU
Non invasive blood pressure
Time Frame: Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU
Systolic and diastolic blood pressure in mmhg
Arrival at the operating room, after bolus administration of drug, at skin incision, at 1,2,5,10,15 min and 10 min after skin incision, every 15 minutes intraoperative, on arrival, 5,10,15,30 min and 1 hour at the PACU
To assess surgeon satisfaction score
Time Frame: 30 minutes after the end of the surgery
Surgeon satisfaction was assessed as follows: 1, extremely dissatisfied; 2, not satisfied but able to manage; 3, satisfied; 4, extremely satisfied.
30 minutes after the end of the surgery
VAS score for pain
Time Frame: at skin closure and at 1hr, 2 hrs. 3hrs and 6 hrs. after PACU admission.
The pain VAS is a unidimensional measure of pain intensity, the score is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
at skin closure and at 1hr, 2 hrs. 3hrs and 6 hrs. after PACU admission.
Time to first rescue analgesic
Time Frame: During the first 24 hours in the postoperative period
The time when the patient first requires analgesia.
During the first 24 hours in the postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2018

Primary Completion (Actual)

August 8, 2018

Study Completion (Actual)

August 9, 2018

Study Registration Dates

First Submitted

May 12, 2018

First Submitted That Met QC Criteria

June 5, 2018

First Posted (Actual)

June 7, 2018

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

December 1, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-28-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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